Tens of thousands of EpiPens recalled for faulty mechanism

ore than 80,000 EpiPens are being recalled across multiple countries because they might fail to work in an emergency, the company announced this week.

The devices included in the recall were distributed in Australia, New Zealand, Japan, and a variety of European countries, but not in the United States, said a spokesperson for Mylan, the company that markets the device.

In two cases, the EpiPens actually did not work, according to a Mylan statement issued on Monday, though the company did not specify whether anyone was injured as a result of the failure. A Mylan spokesperson said that the two individuals were able to use different EpiPens to relieve their symptoms.

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EpiPens are auto-injectors that deliver lifesaving doses of epinephrine to individuals suffering from severe allergic reactions. When pressed into the thigh of a person experiencing anaphylactic shock, it triggers a needle to shoot through the person’s skin and deliver epinephrine directly into the muscle.

The recalled pens may contain a “defective part” that “may result in the device failing to activate or requiring increased force to activate,” according to the company’s statement.

EpiPens can stop a body from going into overdrive when it's exposed to an allergen.Alex Hogan, Hyacinth Empinado/STAT

EpiPens are manufactured by Meridian Medical Technologies, a US-based subsidiary of Pfizer.

According to government agencies, nearly 500 EpiPens have been recalled in Denmark and about 2,000 in Norway, along with an unspecified number in Finland and Ireland.

A Norwegian Medicines Agency news release notes that EpiPens covered under this recall had been for sale in Norway since January 2016.

According to the Mylan statement, the potentially defective EpiPens expire in April.

Patients can trade in their recalled auto-injector for a new one at no cost.

So, why is the FDA slow tracking the Approval of the alternative syringe from Adamis that has proven superiority features to the Mylan Epipen in ease and accuracy of use? Also in proper dose, and can be successfully used by 12 year old children and up compared to 18 and up for Mylan! And the price would be as much as half of the Mylan. Could this be political also? Why did Mylan donate $750,000 to the Clinton Foundation??
Mylan has a monopoly on Epipen and the FDA sits on Data that makes approval of Adamis a No.Brainer. Mmmm.
Like the heck with the emergency needs of consumers who could die from defective Mylan EpiPens. That cost too much now for a billion $$$ more greater market that truly exists over the current one. And the FDA sits back and watches.
What are these FDA 15000 people doing each day???
The whole thing needs to be looked at by the new Director of the FDA….Don’t you think??